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M.E. Garza is one of the founders of the biotech and healthcare sector news portal BioMedReports.com. He believes in getting the news from credible sources on the street and often reaches out to CEOs and newsmakers directly for interviews and discussions about their companies. Since he began... More
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  • RxNews Recap for Friday 02-12-10. Curis (CRIS) up on milestone payment. Labopharm (DDSS) falls on offering.

    Curis, Inc. (NASDAQ: CRIS), saw its shares rise today as the company announced that its licensee Debiopharm S.A. has received approval from France's regulatory authority Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8 million milestone payment from Debiopharm for the achievement of this development objective.

    "We believe that Debio 0932 may have broad potential in a number of cancer indications based on its multiple mechanisms of action and client proteins, and its remarkable pharmacological properties, and we are pleased that the second compound generated from Curis’ proprietary targeted cancer platform has advanced into the clinic," said Dan Passeri, Curis’ President and Chief Executive. "The acceptance by the French regulatory authorities of Debiopharm’s CTA package is an important milestone in the development of this innovative cancer treatment and a testimony to Debiopharm’s regulatory expertise and commitment to Debio 0932."

    "We are excited that Debio 0932 has reached this important milestone and that the clinical studies will start. Debiopharm is committed to the development of this compound and we believe that Debio 0932 can address a major unmet medical need and become an important tool available for the treatment of cancer," said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group™.

    Debiopharm plans to open a Phase I clinical trial evaluating the safety of Debio 0932 during the first quarter of 2010. The study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of multiple doses of Debio 0932 in patients suffering from advanced solid tumors or lymphoma.

    Based on Curis’ research to date, the company believes that Debio 0932 may provide key benefits over Hsp90 inhibitors currently in clinical testing. Curis has evaluated the potency, safety, efficacy and pharmacological properties of Debio 0932 in multiple animal models, where it exhibits high oral bioavailability and selective retention in tumors, crosses the blood brain barrier and displays potent antitumor activity in several animal models when given alone or in combination with standard-of-care agents, while robustly inhibiting multiple signaling pathways, including PI3K/AKT and RAF/MEK/ERK.

    "The $8 million milestone payment provides us with significant additional non-dilutive capital to continue our development of our first-in-class, network-targeted EGFR, Her2 and HDAC inhibitor CUDC-101 and other preclinical network-targeted agents, including an HDAC and Pi3K inhibitor, which we expect to advance as a development candidate in 2010," said Mike Gray, Curis’ Chief Financial Officer. "Curis currently has adequate cash to fund its operations well into the first half of 2012, not including any additional potential future milestone payments from our collaborations with Genentech and Debiopharm."

    Shares of Curis closed up 20 cents or 8.66% to close at $2.51.

     Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) shares traded down today as the company announced that it has priced an underwritten public offering of 11,764,706 newly issued units at a public offering price of US$1.70 per unit. Each unit is comprised of one of the Company's common shares and a warrant to purchase 0.5 of a common share. Each whole warrant entitles the holder to acquire one common share of the Company upon payment of US$2.30 per share, exercisable at any time during the period beginning six months after the date of issuance and ending three years following the date of issuance. The gross proceeds to Labopharm, before underwriting discounts and commissions and other offering expenses, from the sale of the units are expected to be approximately US$20 million. Labopharm closed down 41 cents to close the day at $1.71.

    In other news from a relatively quiet, pre-holiday Friday:

    Agilent Technologies Inc. (NYSE: A) today reported revenues of $1.21 billion for the first fiscal quarter ended Jan. 31, 2010, 4 percent above one year ago.

    Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it will host a conference call and Webcast on Thursday, February 25, 2010, at 8:30 a.m. EST, for Company executives to discuss fourth-quarter 2009 financial and operational results.

    Catalyst Health Solutions, Inc. (NASDAQ: CHSI), a pharmacy benefit management company, will release its fourth quarter earnings results on Tuesday, February 23, 2010, after the market closes.

    CryoPort, Inc. (OTCBB: CYRXD) (NASDAQ:CYPT) today announced that it has decided to postpone its contemplated public offering of units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock, due to unfavorable market conditions.

    Endo Pharmaceuticals (Nasdaq: ENDP) will announce its fourth quarter and full year 2009 financial results on February 22, 2010 and will host a conference call and webcast at 10:30 a.m. ET that day to discuss these results.

    Helix BioPharma Corp. (TSX, FSE: HBP; Pink Sheets: HXBPF) today announced that the first ten patients that have been enrolled in its Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.

    Idant Laboratories, a subsidiary of the medical instrumentation and biotechnology company Daxor Corporation (NYSE Amex: DXR), today announced that it received a blood banking contract from Rotenberg, Meril, Solomon, Bertiger & Guttilla (RMSB&G).

    IntegraMed America, Inc. (NASDAQ: INMD) today announced that it has priced a public offering of 2,500,000 shares of its common stock at a price to the public of $7.50 per share, of which 2,000,000 shares are being offered through the underwriters named below and 500,000 shares are being offered directly by IntegraMed to IAT Reinsurance Company Ltd., IntegraMed’s largest stockholder.

    The approximately $17 million of net proceeds, after deducting underwriting discounts, commissions and expected offering expenses payable by IntegraMed, are intended to be used to accelerate the addition of new partner fertility centers, to accelerate the pace of new vein clinic openings in 2010, or for general working capital and other corporate purposes. The offering is expected to close on or about February 18, 2010, subject to the satisfaction of customary closing conditions.

    The underwriters have been granted a 30-day option to purchase up to an additional 300,000 shares to cover over-allotments, if any

    International Merchant Advisors, Inc. (Pink Sheets: IMAI) announced today that the company has formally offered to purchase an equity position in a pharmaceutical operation that is focused on selling in the chronic pain management medical sector.

    Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a specialty pharmaceutical company focused on difficult-to-formulate drugs, today announced the appointment of Graham Neil, CA, as Chief Financial Officer and Vice-President, Finance.

    Mr. Neil is a Chartered Accountant with over 10 years of public company and healthcare industry experience. Most recently Mr. Neil served as CFO for a NASDAQ- and TSX-listed development-stage company. Prior to his public company experience, Mr. Neil served with KPMG.

    "We are very pleased to announce the appointment of Graham Neil to the position of CFO and VP of Finance," commented Dr. Isa Odidi, Chief Executive Officer and co-founder of Intellipharmaceutics. "Graham will be a very valuable addition to our executive team as we advance our pipeline of products, including our lead product candidate Dexmethylphenidate XR, a generic version of the marketed drug Focalin XR®. This product is partnered with Par Pharmaceutical and is currently the subject of an Abbreviated New Drug Application filing with the FDA."

    MMR Information Systems, Inc. (OTCBB:MMRF) Dear Shareholder:  As we go into the long Valentine's and Presidents Day holiday weekend, I want to take this opportunity to express MMR Information Systems' appreciation for your support as we mark our first anniversary as a public company.Time goes fast when you are committed to a vision.

    NeoStem, Inc. (NYSE Amex: NBS), an international biopharmaceutical company with operations in the U.S. and China, announced today that it priced a public offering of 5,000,000 shares of its common stock at $1.35 per share. Net proceeds from the offering, after underwriting discounts and commissions and expenses, will be approximately $5,697,500. NeoStem has granted the underwriters an option to purchase up to an additional 750,000 shares to cover over-allotments, if any.

    "We were pleased by the participation of new institutional investors as well as the additional investment by our largest shareholder and other insider participation," noted Dr. Robin Smith, Chairman and CEO. "We remain committed to expanding our revenue opportunities in China, both through our pharmaceutical business and soon to be launched adult stem cell initiatives. The proceeds of this offering will help us reach our goals."

    The Company intends to use the net proceeds from this offering for the construction of manufacturing and lab facilities in China and the U.S., stem cell-related research and development projects, development and licensing of new pharmaceutical products in China, and for working capital and general corporate purposes.

    Neurologix, Inc. (OTCBB:NRGX), a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, today announced that it has hired MTS Health Partners, L.P. as strategic advisor to complement and augment the company’s ongoing business development activities.

    Perrigo Company (Nasdaq: PRGO) announced today that a federal court has granted summary judgment in its favor in patent litigation involving Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex® tablets. Perrigo had been sued by Adams Respiratory Therapeutics, Inc., (a subsidiary of Reckitt Benckiser Group plc.) the New Drug Application holder and patent owner. The United States District Court for the Western District of Michigan ruled today that Perrigo does not infringe the patent in the suit. Perrigo's ANDA is awaiting FDA approval.

    Perrigo's Chairman and CEO Joseph C. Papa stated,This is another example of Perrigo's significant investment and commitment to bringing new store brand products to the market. This will be an important new store brand product addition in the cough/cold category to our retail and wholesale customers while providing significant savings for the U.S. consumer. Perrigo is working every day to make quality healthcare more affordable.

    Rexahn Pharmaceuticals (AMEX:RNN) continued its rally, closing up over 28% on heavy volume to close the day at $1.22. The shares are up over 50 cents or 80% since BioMedReports first reported on the company on Tuesday.

    Senomyx, Inc. (NASDAQ: SNMX) announced today the pricing of an underwritten public offering of 7,142,857 shares of its common stock at a price to the public of $2.80 per share.

    Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) was up over 17.5% on more than double the normal volume to close at $1.07 on no apparent news.

    3SBio Inc. (Nasdaq:SSRX), a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, announced late last night (Thursday) that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA). NuPIAO is a highly glycosylated ESA (erythropoiesis-stimulating agent) with extended half-life and increased biologic activity. Pre-clinical results showed a promising pharmacokinetic profile which would allow a once weekly injection schedule of NuPIAO in humans. NuPIAO will be investigated to treat anemia associated with both chronic kidney disease and cancer.

    "This submission represents another important milestone in our effort to extend our market leading EPO franchise and continue to serve the needs of patients in China," said Dr. Jing Lou, CEO of 3SBio. "It is a direct result of our dedicated R&D effort to generate an innovative pipeline and create long term value for shareholders."

    In a separate release 3SBio announced that they have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis with Ascentage Pharma Group Corporation, Ltd.. The alliance will leverage Ascentage Pharma's expertise in structure-based small molecule design, lead optimization and pre clinical development with 3SBio's proven drug development and commercialization capabilities in China.

    Under the terms of the agreement, 3SBio will make a US$3 million equity investment in Ascentage Pharma. The investment will be used to fund Ascentage Pharma's R&D programs. 3SBio will have the exclusive right to develop and commercialize cancer therapeutics in China that are discovered through Ascentage Pharma programs, while Ascentage Pharma will retain the rights to the rest of the world and receive future milestone and royalty payments from any sales by 3SBio in China.

    "The collaboration with Ascentage Pharma represents a key strategic initiative for 3SBio to develop our pipeline in the area of cancer therapeutics," said Dr. Jing Lou, CEO of 3SBio. "This investment allows 3SBio to gain access to the best external science and small molecule drug discovery platform in China."

    And finally, the company also announced its unaudited financial results for the fourth quarter and full year ended December 31, 2009.

    Shares traded higher on Friday by 16 cents to close at $11.15.

    Walgreens (NYSE: WAG)(NASDAQ: WAG) will continue filling Medicaid prescriptions at its Washington state pharmacies through March 15.


    Feb 12 8:16 PM | Link | Comment!
  • RxNews Recap for Thursday 02-11-10. OPKO Health (OPK) soars on Alzheimers Test. Amicus (FOLD) jumps on Phase 2 data. Cadence Pharma (CADX) drops on FDA CRL

    OPKO Health, Inc. (Amex:OPK) saw its shares jump 11.5% today as the company announced the development of a simple diagnostic blood test for Alzheimer’s disease. The test, designed to detect elevated levels of antibodies unique to Alzheimer’s disease, was approximately 95% accurate in initial testing.

    The novel Alzheimer’s disease-specific antibodies were discovered using a proprietary platform being developed by OPKO that appears to be capable of identifying such biomarkers for any disease to which the immune system reacts, including cancer, autoimmune disease, neurodegenerative and infectious diseases. OPKO will perform additional studies required for regulatory approval and commercial use. The test could be useful in identifying patients for clinical trials for new Alzheimer’s drugs as well as to confirm the diagnosis in a clinical setting.

    Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, stated, "OPKO has begun to develop a range of new diagnostic tests for other neurological diseases, as well as cancers, starting with those for which early diagnosis is particularly important."

    Shares of OPKO rose 20 cents to close the day at $1.94. Volume was nearly 10 times the daily average.

    Amicus Therapeutics (Nasdaq: FOLD) announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal(migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida. The Company also presented encouraging data from preclinical studies evaluating the combination of pharmacological chaperones and enzyme replacement therapy (NASDAQ:ERT) for Fabry disease and Pompe disease as well as from preclinical studies examining the use of pharmacological chaperones for the treatment of Parkinson's disease.

    John F. Crowley, Chairman and CEO of Amicus Therapeutics, added, "We are very pleased with the continued positive Amigal data and remain confident that our Phase 3 program will be successful. Our focus is the completion of enrollment in Study 011 this year and the commencement of Study 012. We are also very encouraged by the results of our preclinical studies of the chaperone-ERT combination approach as well as the advancements with our Parkinson's program. We look forward to moving these applications of our technology forward in 2010."

    Shares closed up 38 cents or 11.38% to $3.72 and were up another 3% in the after hours market.

    Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for intravenous (IV) acetaminophen.

    In the Complete Response letter, the FDA only indicated that deficiencies were observed during the FDA's facility inspection of Cadence's third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval.

    The Company's third party manufacturer intends to respond promptly to the observations, and Cadence plans to request a meeting with the FDA to ensure that the deficiencies have been adequately addressed to meet the requirements for NDA approval.

    Cadence noted that the U.S. Food and Drug Administration did not cite any safety or efficacy issues for the drug, nor did it request any additional studies to be conducted prior to approval.

    Canaccord Adams analyst Adam Cutler, who termed the manufacturing issues as minor, said more importantly there were no safety or efficacy issues and expects the drug to get an approval later this year.

    "People can view the approval most likely to be a 'when' issue not an 'if' issue," said the analyst, who has a "buy" rating on Cadence' shares.

    Shares fell 7.98% on the news to close the day down 82 cents to $9.46.

    In news from after the market close:

    Cephalon, Inc. (Nasdaq: CEPH) after the bell today reported 2009 net sales of $2.152 billion, an 11 percent increase compared to net sales of $1.943 billion for 2008. Basic income per common share for the year was $4.74. Excluding amortization expense and certain other items, adjusted net income for full year 2009 was $469 million, a 28 percent increase over the previous year. This exceeded the company's adjusted net income guidance range of $457 to $464 million for 2009. Basic adjusted income per common share for the year was $6.48 in 2009 and $5.39 in 2008. "2009 was a year of extraordinary innovation and growth," said Frank Baldino, Jr., Ph.D., Chairman and CEO. "For the year we reported positive clinical study results on several of our drug candidates, advanced five new compounds into man and continued to acquire promising assets. We continue our steadfast commitment to patients while building an enduring, diversified business for our shareholders."

    Theravance, Inc. (NASDAQ:THRX) reported today its financial results for the fourth quarter and full year ended December 31, 2009. Revenue for the full year was $24.4 million which included $0.8 million in royalties related to sales of VIBATIV (telavancin) which was launched during the fourth quarter. Net loss for the fourth quarter and full year of 2009 was $22.2 million and $85.3 million, respectively, compared with $15.9 million and $93.6 million for the same periods of 2008. Net loss per share was $0.35 and $1.35 for the fourth quarter and full year of 2009, respectively, compared with a net loss per share of $0.26 and $1.53 for the same periods of 2008.

    "It was a very exciting fourth quarter for Theravance with the initiation of the large Phase 3 RELOVAIR? program with GSK in COPD and the commercial launch of VIBATIV for complicated skin and skin structure infections in the United States with our partner, Astellas, as well as approval in Canada," said Rick E Winningham, Chief Executive Officer. "Enrollment in the Phase 3 RELOVAIR program in COPD is progressing well. I am particularly pleased that VIBATIV is receiving positive reception from physicians in the U.S. and that Astellas generated net sales of $4.3 million following the November launch. 2009 was a productive year for Theravance and we look forward to the progress of the RELOVAIR program and further development of our pipeline in 2010."

    ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported its financial results for the fourth quarter and year ended December 31, 2009. For the fourth quarter, the company had net income of $13.6 million, or $0.19 per diluted share, compared to a net loss of $9.2 million, or $0.13 per share, for the same quarter in the prior year. For the full year 2009, the company reported a net loss of $43.0 million, or $0.62 per share, compared to a net loss of $116.2 million, or $1.69 per share, for the prior year. The profitable fourth quarter of 2009 resulted from the one-time recognition of $34.4 million of previously deferred revenue triggered by amendments to the RECOTHROM® Thrombin, topical (Recombinant) license and co-promotion agreements with Bayer. The decrease in the net loss for the full year was attributable to increased license and collaboration revenues from the PEG-Interferon lambda collaboration with Bristol-Myers Squibb; the recognition of deferred revenue resulting from the amendments to the Bayer agreements; increased RECOTHROM sales, which tripled versus the prior year; and reduced research and development expenses.

    In other news Thursday:

    Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. Norvir is used in combination with other antiretroviral medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid form, remain available in the United States.

    "Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV," said Scott Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years."

    Advanced Cell Technology, Inc.(OTCBB:ACTC) reported that a range of therapeutic cell types obtained from induced pluripotent stem (iPS) cells exhibit abnormal expansion and early cellular aging.

    Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) shares rose over 7.5% as the company announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials. In February 2010, Alexza established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE: BVF), to develop and commercialize AZ-004 in the U.S. and Canada.

    Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial results for the quarter and year ended December 31, 2009. For the three months ended December 31, 2009, Alexion Pharmaceuticals, Inc. ("Alexion" or, the "Company") reported net product sales of Soliris® (eculizumab) of $110.6 million, reflecting strong additions of new patients, compared to $77.4 million for the same period in 2008.

    BioCurex Inc. (OTCBB:BOCX), a biotechnology company developing products based on patented technology in the areas of cancer diagnostics, today announced that it has launched the commercialization of its OncoPet RECAF test for cancer detection in dogs.

    Biodel, Inc. (Nasdaq: BIOD) announced today that its chief executive officer, Dr. Sol Steiner, will present results from the company’s two Phase 3 studies with VIAject® ultra-rapid-acting recombinant human insulin in a platform presentation at the 3rd International Conference on Advanced Technologies and Treatments for Diabetes in Basel, Switzerland, on Friday, February 12, 2010, at 1pm central European time. The presentation, entitled "Clinical Findings for Patients Treated with VIAject®, An Ultra-Rapid Acting Formulation of Recombinant Human Insulin," will review and update key data from the VIAject® clinical development program. Dr. Steiner’s presentation will be available on the company’s website, Biodel.com, after the presentation.

    Shares of Biodel were up a hefty 44 cents or 12.75% on double the normal volume to close the day at $3.89

    BioMed Realty Trust, Inc. (NYSE: BMR), a real estate investment trust focused on Providing Real Estate to the Life Science Industry®, today announced financial results for the fourth quarter and full-year ended December 31, 2009. "BioMed's robust business model and disciplined execution were clearly evident from the strong results of the fourth quarter and full-year 2009," said Alan D. Gold, BioMed's Chairman and Chief Executive Officer. "Powerful long-term demand drivers for the life science industry continue to fuel drug research and development efforts throughout the seven core life science markets which, in turn, attract capital used to fund mission-critical laboratory space. Despite macro-economic headwinds, BioMed succeeded in leasing more than 1.5 million square feet of laboratory and office space in 2009 and delivering over one million square feet of space from our development pipeline, which was collectively 91% leased at year-end, to premier research institutions and large, publicly traded companies. These exceptional results in 2009, and throughout our five-year history, demonstrate the ability of our outstanding team of professionals to support the life science industry's real estate needs and position the company well for future growth opportunities, continuing to create value for our shareholders." The company's tenants primarily include biotechnology and pharmaceutical companies, scientific research institutions, government agencies and other entities involved in the life science industry. BioMed owns or has interests in 69 properties, representing 112 buildings with approximately 10.5 million rentable square feet. The company's properties are located predominantly in the major U.S. life science markets of Boston, San Diego, San Francisco, Seattle, Maryland, Pennsylvania and New York/New Jersey, which have well-established reputations as centers for scientific research.

    BSD Medical Corporation (NASDAQ:BSDM) today announced that it entered into a securities purchase agreement with two institutional investors for the sale of 1,176,471 shares of its common stock in a registered direct offering at $1.70 per share. In addition, warrants to purchase 882,354 shares of common stock in the aggregate will be issued to the investors. The warrants are exercisable beginning six months and one day after closing, expire 5 years after becoming exercisable and have an exercise price of $2.04 per share. Gross proceeds of the offering, before deducting placement agent fees and other estimated offering expenses payable by BSD Medical Corporation, are expected to be approximately $2 million. These securities are being offered through a prospectus supplement pursuant to the Company’s effective shelf registration statement and base prospectus contained therein. Shares of BSD traded down 21 cents to close at $1.70.

    Cambridge Heart, Inc. (OTCBB- CAMH), today announced that the Company has completed the development phase of its Microvolt T-wave Alternans (MTWA) OEM Module, and has submitted a 510(k) application for regulatory approval with the U.S. Food and Drug Administration (FDA).

    Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, in combination with carbidopa has been initiated in adult attention deficit hyperactivity disorder (NASDAQ:ADHD).

    ADHD is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, and other disruptive behavioral issues. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the U.S. adult population, or between 8-9 million individuals. As adult ADHD is characterized as a disorder of decreased norepinephrine (NYSE:NE) activity in the pre-frontal cortex, it is hypothesized that by limiting the peripheral metabolism of Droxidopa into NE through co-administration of carbidopa, the enhanced central levels of Droxidopa may have a positive therapeutic effect in adult ADHD.

    China Pediatric Pharmaceuticals, Inc. (OTC Bulletin Board: CPDU), today announced it has recently closed a private placement financing.

    Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) saw its shares jump 18.27% or 33 cents to $2.33 on heavier than normal volume. Cyclacel is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. Three orally-available Cyclacel drugs are in clinical development.

    Emergency Medical Services Corporation (NYSE: EMS) today announces results for the fourth quarter and year ended December 31, 2009.

    William A. Sanger, Chairman and Chief Executive Officer, said, "EMSC had another banner year in 2009. In more than 13 million patient encounters, our clinicians provided care with an emphasis on quality, safety, compassion and dignity. We produced strong organic growth, won a significant number of new contracts, and enhanced our market position with targeted acquisitions. We believe the actions taken in 2009 position us well for the opportunities in 2010 and beyond." Shares closed up $2.03 to close at $53.88.

    Genzyme Corporation (NASDAQ: GENZ) announced today two-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline.

    Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV) today announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska™ (intranasal ketamine) showed that top line results for its primary endpoint were statistically significant. Previously, Javelin had reported that the top line results for its primary endpoint were not statistically significant. The previously disclosed top line results, based upon data captured by an external vendor, had inconsistencies whose presence was verified by a third party biostatistics company engaged by Javelin that thoroughly reexamined the trial’s conduct and the initial primary analysis. The third party’s correction of these inaccuracies yielded today’s results. As previously disclosed, global patient satisfaction scores for Ereska were also statistically superior to placebo. All other secondary endpoints, while numerically superior to placebo, did not achieve statistical significance. Ereska, a nonopioid analgesic, was generally well tolerated in the trial. The Company plans to meet with the FDA to review the trial’s results and discuss Ereska’s registration program. Shares of Javelin closed the day up .07 or 5.88% to $1.26.

    Kendle (Nasdaq: KNDL) announced today that it will release its fourth quarter and full-year 2009 financial results after the market closes on Wednesday, Feb. 24, 2010.

    Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced results for the quarter and year ended December 31, 2009.

    Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the fourth quarter and year ended December 31, 2009. "Momenta is poised for a pivotal year in 2010," commented Craig A. Wheeler, President and Chief Executive Officer. "We continue to believe the FDA will approve the ANDA for generic Lovenox®. Together with our collaborative partner Sandoz, we are prepared for a potential launch. The FDA review of the ANDA for the second complex mixture product in our pipeline, generic Copaxone®, is also well underway. Our novel drug candidates, products of Momenta's proprietary analytical platform, are advancing. We begin 2010 financially strong and committed to developing needed medications that will deliver value to patients," he concluded.

    NovaMed, Inc. (Nasdaq: NOVA), a leading operator of ambulatory surgery centers in partnership with physicians, today announced results for the fourth quarter and year ended December 31, 2009. Total net revenue grew to $39,809,000, up 10% from $36,177,000 in the prior year fourth quarter. Same-facility net revenue growth was 6% for the quarter. "NovaMed continues to execute well in a difficult environment as demonstrated by our fourth quarter results and the significant improvement in our same-facility revenue growth," commented Thomas S. Hall, Chairman, President and Chief Executive Officer of NovaMed, Inc. "December was a very strong month for surgical procedures performed in our surgery centers. While we are encouraged by the continuing improvement in same-facility revenue growth, we remain cautious as to how this trend will develop over the next several quarters. Our strong cash flow from operations of $6.3 million was 3.5 times net income from continuing operations attributable to NovaMed. With capital expenditures of $416,000 in the quarter, our free cash flow of $5.9 million continued to allow us to deleverage our balance sheet in the fourth quarter."

    Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (NYSE:AMN), HIV and Multiple Sclerosis (NYSE:MS), has announced today that it has hired David Isserman to serve as its Chief Marketing Officer.

    OlFactor Laboratories, Inc. (OLI), a majority owned subsidiary of Avisio, Inc. (PINKSHEETS: AVIC), announced today that the company has acquired an exclusive license to patented technology from UC Riverside.

    Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2009, on Wednesday, February 24, 2010. C. Randal Mills, Ph.D., President and Chief Executive Officer, and Philip R. Jacoby, Jr., Chief Financial Officer, will provide a company update and discuss results via a webcast and conference call on Wednesday, February 24, 2010 at 9:00 a.m. ET.

    OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today a restructuring plan designed to focus resources on the company's highest-value clinical assets and reduce its cash utilization.

    The company plans to cut its workforce in half, as the company will stop enrolling new patients in a trial for its thyroid cancer treatment. The biopharmaceutical company now plans to focus its Phase II Zybrestat trial in non-small-cell lung cancer.

    Oxigene said the restructuring will cost $600,000, while saving the company $2.6 million annually, beginning in the second quarter.

    Last week, VaxGen Inc. (OTCBB:VXGN) shareholders voted down a $22 million buyout offer from Oxigene.

    Shares of Oxigene fell 5.3% to close the day at $1.23.

    Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported publication of data in the online edition of the journal Current Cancer Therapy Reviews that supports the clinical potential of the company's novel brain cancer agent Cotara® for the treatment of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer.(1) Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is currently being tested in a Phase II clinical trial in recurrent GBM patients.

    The new data from investigators at the Huntsman Cancer Institute at the University of Utah Medical Center and researchers at Peregrine Pharmaceuticals reports on long-term patient follow-up from an earlier Phase I trial in 28 GBM patients with recurrent disease. Data presented from the study showed that seven of 28, or 25% of the patients survived more than one year after treatment and three of the 28, or 10.7% of the GBM patients treated in this study have survived more than five years after treatment, including two patients who have survived more than nine years, a positive finding compared to the 3.4% five-year survival rate from initial diagnosis reported by the U.S. Brain Tumor Registry. Additionally, the median survival time of the 28 patients was 38 weeks, a 58% increase over the historical median survival time of 24 weeks for GBM patients treated with standard-of-care therapy.

    Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that additional data from the Company's pivotal Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida, during an oral session titled, "Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant Cell Expressed Recombinant Glucocerebrosidase (prGCD) - taliglucerase alfa." The oral presentation was made by Hanna Rosenbaum M.D., Director of Hematology Day Care Unit, RAMBAM Medical Center, Haifa, Israel, and study investigator.

    "I believe the data from the Phase III trial demonstrates that taliglucerase alfa is well tolerated and clinically effective in treating Gaucher disease," said Dr. Hanna Rosenbaum.

    pSivida Corp. (NASDAQ: PSDV), a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its second quarter and six months ended December 31, 2009.

    QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and Celera Corporation (NASDAQ:CRA) today announced an agreement under which QIAGEN will distribute a Celera molecular multiplex assay. The assay is the next generation version of QIAGEN's ResPlex II assay for detection of respiratory pathogens. Multiplex assays allow testing for a multiple number of different pathogens in a single run. Financial details were not disclosed.

    Under the terms of the agreement, QIAGEN has the exclusive worldwide rights to distribute this multiplex test kit, which will be manufactured by Celera. The new ResPlex assay detects 19 different pathogens associated with respiratory infections and is designed for use with LiquiChip (Luminex) 100 and 200 instrument platforms.

    Roche NimbleGen (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) announced today that Beijing-based genomic services provider CapitalBio has officially joined the Roche NimbleGen Certified Service Provider (NYSE:CSP) Program.

    Rexahn Pharmaceuticals, Inc. (Amex:RNN), continued to trade higher today after a story and CEO interview featured here yesterday on BioMedReports highlighted the companies "multi-indication" therapeutics that position the company for long-term success. Shares were up 16 cents or 20% to $.95 and continued higher in the after hours session.

    Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today presented positive results from its first phase III study (TKT 032) evaluating safety and efficacy of velaglucerase alfa, its investigational enzyme replacement therapy for the treatment of Type 1 Gaucher disease.

    Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today reported its financial results for the fourth quarter and year ended December 31, 2009.

    Vical Incorporated (Nasdaq:VICL) today reported financial results for the year ended December 31, 2009. Vical had cash and investments of approximately $53 million at year-end 2009. The company raised approximately $33 million of net proceeds from the sale of equity securities during 2009, and approximately $3 million of additional net proceeds from the sale of equity securities to date in 2010.

    Revenues for 2009 were $12.7 million, compared with revenues of $8.0 million for 2008. The net loss for 2009 was $28.6 million, or $0.61 per share, compared with a net loss of $36.9 million, or $0.93 per share, for 2008. The net cash burn for 2009, excluding financing activities, was approximately $22 million, compared with approximately $34 million for 2008. The decline in net cash burn was driven primarily by cost savings resulting from the company's November 2008 restructuring and staff reduction, as well as the increase in revenues. The company is projecting a net cash burn for 2010 of between $20 million and $24 million, including anticipated receipts from new or expanded partnerships not currently contracted.

    Shares traded higher by 23 cents or 8% to close at $3.10.

    Viral Genetics (Pink Sheets: VRAL) -- saw its shares jump over 24% today on heavier than usual volume as the company provided an update on the "State of the Company".

    Our mission is to bring new drug compounds to the marketplace. And we've never been in a stronger position to deliver on that promise. We've built the solid foundation needed to take drug therapies from the laboratory to the marketplace. After years in development, we believe several of our most promising compounds are moving closer to clinical trials.

    During 2009, Viral Genetics made significant strides on two fronts -- scientific and financial. Our drug compounds seem to be showing great potential. Additionally, we've built an infrastructure that enables us to use money wisely. We have retired nearly all of our external debt, enabling us to leverage any additional funding to advance new drug therapies -- rather than making interest payments to creditors.

    XenaCare Holdings, Inc. (OTCBB:XCHO), a company specializing in the marketing and retail distribution of consumer healthcare products, announced today that it has begun distributing and selling Cobroxin through mass food and drug retail chains in the Northeast, Southeast, Middle Atlantic and Midwest regions.
    Feb 11 11:16 PM | Link | Comment!
  • RxNews Recap for Wednesday 02-10-10. Athersys (ATHX) jumps on patent. China-Biotics (CHBT) soars after hours.
    Below is a list of the companies that made news in the healthcare sector on Wednesday, February 10, 2010.

    Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

    Athersys, Inc. (Nasdaq:ATHX) saw its shares rally over 14% as the company announced today that it has been granted U.S. patent 7,659,118 that covers non-embryonic multipotent stem cells, their isolation and expansion, and related pharmaceutical compositions. Athersys also announced that it has been granted and the opposition period has cleared EP patent EP1218489B1 that covers non-embryonic pluripotent stem cells, their isolation, expansion, and usage.

    The issued patents cover Athersys' proprietary scalable MultiStem® technology, which is an investigational stem cell therapy that has demonstrated therapeutic potential to treat a broad range of diseases and indications, including acute myocardial infarction, inflammatory bowel disease (IBD), bone marrow transplant support and ischemic stroke. Athersys announced in December 2009 a strategic partnership with Pfizer under which the companies will jointly develop MultiStem for IBD.

    "These patents further expand our stem cell IP estate and offer additional validation of the strength and breadth of the Athersys IP portfolio," said William (B.J.) Lehmann, President and COO of Athersys. "We believe that these patents are especially important as they extend the coverage of the composition, isolation, differentiation and scalable manufacturing of non-embryonic stem cells that are core to our technology and product portfolio."

    Shares of Athersys were trading up as much as 32% in the pre-market and ended the day up 41 cents or 14.24% to close at $3.29.

    China-Biotics, Inc. (Nasdaq: CHBT) saw its shares soar after the bell as the leading Chinese firm specializing in the manufacture, research, development, marketing and distribution of probiotics products, today announced its financial results for the third quarter of its 2010 fiscal year ended December 31, 2009 including revenues that exceeded expectations.

    "Our robust fiscal third quarter revenue and earnings growth reflect the Company's continued expansion of our bulk and retail customer bases," said Mr. Jinan Song, Chairman and Chief Executive Officer of China-Biotics. "Commercial production at our Qingpu production plant is scheduled to begin by the end of February and we continue to expect to reach approximately 50% capacity utilization by the end of calendar year 2010. With rising demand from the dairy and animal feed manufacturers, and movement by the government to encourage the use of probiotics, China continues to be a very favorable environment to grow our bulk and retail probiotics business in 2010 and beyond." Mr. Song went on to say  "The Company is reiterating its fiscal year 2010 revenue growth guidance of at least 50% and expects overall gross margin to remain approximately 70%. "We will continue to seek a balance between current production capacity and sales to new customers until our new facility begins commercial production. We look forward to the continued expansion of our retail distribution network and outlets. Once the Qingpu facility comes online, we will have the capacity to accommodate new orders as scheduled, which will begin contributing to our financial results in the fourth quarter of fiscal 2010."

    China-Biotics, Inc., a leading manufacturer of biotechnology products and supplements, engages in the research, development, marketing and distribution of probiotics dietary supplements.

    Shares were up in the after hours session $1.10 or 8.30% to $14.34.

    Other news after the market closed:

    Hanger Orthopedic Group, Inc. (NYSE: HGR) jumped after the bell as the company announced net sales of $205.1 million for the quarter ended December 31, 2009, an increase of $19.6 million, or 10.6%, from $185.5 million in the prior year. Earnings per share for the fourth quarter of 2009 were $0.37 per diluted share compared to proforma earnings per diluted share of $0.26 for the same period in 2008, a 42.3% increase. "The year 2009 presented a challenging environment due to the uncertainty surrounding proposed changes to federal health care regulations and reimbursement and the impact of the ongoing recession. In spite of these challenges, we delivered record sales, profits and cash flows," commented Thomas F. Kirk, President and Chief Executive Officer of Hanger Orthopedic Group. Mr. Kirk added, "The combination of an 8.1% increase in revenue and a focused effort on expense management generated an 80 basis point improvement in our operating margin. I am proud of our employees' efforts in 2009 and I am optimistic about our opportunities in 2010."

    Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative drug discovery and development company, announced after the market closed that it has commenced clinical development of its fourth internally discovered drug candidate, IPI-940, a novel inhibitor of the enzyme fatty acid amide hydrolase, or FAAH. In addition, Infinity announced progression of its oncology programs consistent with its 2010 guidance, and 2009 financial results.

    "We believe we are well positioned to show the impact that all four of our clinical candidates can have in patients' lives," added Adelene Q. Perkins, president and chief executive officer. "Infinity is financially strong, with a cash runway into 2013. We remain focused on using this strength to continue building Infinity's product pipeline through investment in internal and potential external opportunities."

    In news from earlier in the day:

    Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE: BVF), to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system.  Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. "We are very excited to be partnering our lead program with Biovail. Their key strategic focus and their CNS commercial plans match our view of an ideal partner for AZ-004," said Thomas B. King, Alexza President and CEO. "We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients' desire for quickly and comfortably gaining control of their agitation, and the clinicians' goal of rapidly and reliably calming an agitated patient.

    Angeion Corporation (NASDAQ: ANGN) today announced that it will release its fiscal 2010 first-quarter results on Wednesday, February 24, 2010, at market close.


    A.P. Pharma, Inc. (Nasdaq:APPA) shares jumped 17.85% or $.29 to close at $1.99 on heavy volume and no apparent news. A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s primary focus is on its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The New Drug Application (NDA) for APF530 was submitted to the U.S. Food and Drug Administration (FDA) in May 2009 and accepted for review in July 2009, at which time the FDA set a Prescription Drug User Fee Act (PDUFA) date of March 18, 2010.

    AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the United States Patent and Trademark Office (USPTO) has issued the Company a new patent for its lead drug candidate Zenvia™ (dextromethorphan/quinidine), extending the period of patent protection in the United States into late 2025. U.S. patent number 7,659,282 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders" was issued on February 9, 2010.

    BioClinica™, Inc. (NASDAQ: BIOC), a global provider of clinical trial services, today announced its financial results for the quarter and year ended December 31, 2009.

    BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere” or the “Company”) - the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – today reported financial results for the three and 12 months ended December 31, 2009.

    Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc. BLS has acquired the U.S. and Canadian rights to commercialize AZ-004 – a novel formulation of loxapine administered via deep lung inhalation using Alexza’s proprietary Staccato® device. AZ-004 is initially targeted for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

    Candela Corporation, a Syneron company (Nasdaq: ELOS), announced today that the SFDA (State Food and Drug Administration) of China has approved the Alex TriVantage® multi-wavelength, Q-switched laser system and the GentleMax® multiple wavelength workstation for sale throughout the People's Republic of China, including Hong Kong. The receipt of the SFDA Certificates will allow Candela to begin the sales process and launch official marketing programs for these products, creating a host of new market opportunities.

    Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial. Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (NYSE:SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (NYSEMKT:RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.

    Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced the commercial launch of a new lung cancer test, Clarient Insight® Dx Pulmotype® Test, that helps physicians classify specific types of lung cancer to identify which therapies may be most effective. The new test has been clinically validated to use in the sub-classification of patients with non-small cell lung cancer (NSCLC), which accounts for approximately 85 percent of the more than 200,000 lung cancer cases diagnosed each year.

    "Pulmotype provides pathologists with a valuable new tool to help their oncologist clients understand which patients are eligible for a number of new therapies now available for the treatment of NSCLC," said Chief Executive Officer Ron Andrews. "Its ability to accurately sub-classify lung cancer will enable physicians to make much more informed and effective therapy decisions. We have built a very strong breast cancer franchise and established Clarient as the 'go-to' laboratory for complex breast cancer testing. Pulmotype allows us to offer a similar compelling reason for pathologists and oncologists faced with critical decisions in lung cancer to send the primary tumor samples to Clarient.  Having the lung cancer sample in our hands at the beginning of the diagnostic process allows us to assist the pathologist and the oncologist throughout the patient care process by delivering information on additional molecular markers, such as EGFR mutation and KRAS."

    Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that a medicinal chemistry paper related to the discovery of CUDC-101, Curis’s HDAC, EGFR and Her2 inhibitor, was published online in the Journal of Medicinal Chemistry and also will be published in an upcoming print version of the journal. The paper describes the structure-based rational drug design, synthesis and structure-activity relationship (NYSE:SAR) of a class of novel compounds that included CUDC-101 and the identification of CUDC-101 as a clinical candidate. Related in vitro and in vivo data associated with these compounds are also included.

    Dyax Corp. (NASDAQ:DYAX) will host a webcast and conference call, including an open question and answer session, Wednesday, February 17, 2010, to discuss its financial results and company progress for the fourth quarter and year ended December 31, 2009.

    Genta Incorporated (OTCBB: GETA) announced that it has received $2.8 million in non-dilutive cash proceeds from the sale of net operating tax losses and research tax credits generated in prior tax years as part of the Technology Business Tax Certificate Program sponsored by the New Jersey Economic Development Authority (NJEDA), pursuant to the rules, regulations and stipulations set forth by the program.

    Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.

    All of the 124 patients in the study had pre-existing coronary artery disease, were taking a maximally tolerated dose of a statin and in many cases additional lipid-lowering drugs. Patients’ average LDL-C at baseline was 150 mg/dL. Patients treated with mipomersen had an average LDL-C level of 104 mg/dL at the end of the study. Forty-five percent of the mipomersen-treated patients achieved LDL-C levels of less than 100 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients’ existing therapeutic regimens.

    “The average reduction in LDL-C of 28 percent in these high-risk, difficult-to-treat patients with severe inherited high cholesterol is very encouraging,” said Evan A. Stein, M.D., Ph.D., Director of the Metabolic & Atherosclerosis Research Center, Cincinnati, Ohio, and an investigator on the study. “The nearly 50 mg/dL additional decrease in LDL-C when added to maximally tolerated statin therapy is above what we have seen with any other agent in this population, and the side effect profile of mipomersen continues to be acceptable.”

    But shares of both companies fell with Isis getting hit particularly hard as it dropped 18.66% as a possible signal of liver toxicity seen in prior trials re-emerged.

    Health Discovery Corporation (OTCBB: HDVY) as reported earlier today on BioMedReports announced that the Company has entered into an exclusive agreement with the Pancreas, Biliary and Liver Surgery Center of New York at Saint Vincent Catholic Medical Centers in New York City to provide clinical specimens to be utilized to complete the final validation of HDC's molecular diagnostic test for colon cancer. This test demonstrated a 93% Sensitivity and a 93% Specificity in a previous validation study.

    Today’s announcement is in addition to last week’s press release announcing a new collaboration with the Pancreas, Biliary and Liver Surgery Center of New York related to the discovery of a new molecular diagnostic test for pancreatic cancer.
    There are an estimated 1.2 million new cases of colorectal cancer worldwide and approximately 637,000 deaths from the disease.

    “We are very excited about the results of our previous validation study and look forward to achieving the same success in this final validation," said Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation. “If we are successful in finding the molecular signature in blood as we were in tissue, HDC will have both a tissue-based colon cancer test to be used on biopsy specimens as well as a blood test which can be used as a screening test for colon cancer,” said Dr. Barnhill.

    Under the terms of the agreement, the Pancreas, Biliary and Liver Surgery Center of New York will provide specimens from their collected specimen banks, as well as blood and tissue specimens on all new patients along with all associated clinical and outcomes data.

    Health Discovery Corporation owns all of the intellectual property and commercialization rights to this molecular diagnostic test for colon cancer and HDC intends to partner with a large clinical laboratory for development, marketing and commercialization of this new colon cancer test.

    In developing this new molecular diagnostic test for colon cancer, Health Discovery Corporation employed the same discovery process that led to the urine-based prostate cancer test that is licensed for development and commercialization to Quest Diagnostics (NYSE: DGX) and Abbott (NYSE: ABT) on a royalty-based, world-wide co-exclusive basis.

    Hythiam, Inc. (NASDAQ:HYTM) announced today that the results of a double-blind, placebo-controlled study on the impact of the medical component of the PROMETA® Treatment Program on methamphetamine dependent subjects were published in the Journal of Psychopharmacology, a peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology. The journal provides a forum for researchers and practicing clinicians on the effects of drugs on animal and human behavior, and the mechanisms underlying these effects. The article was recently released and is titled, “A Controlled Trial of Flumazenil and Gabapentin for Initial Treatment of Methylamphetamine Dependence,” Urschel III, Harold C., Hanselka, Larry L., and Baron, Michael, J Psychopharmacol OnlineFirst, November 25, 2009, doi:10.1177/0269881109349837. The results of the 30-day study were analyzed on an intent-to-treat basis that included all randomized participants, and missing days were counted as positive for methamphetamine use. The final data demonstrated that the medical component of the PROMETA Treatment Program achieved a statistically significant reduction in the combined craving score for methamphetamine when compared to placebo, and that craving was a significant predictive factor for subsequent drug use.

    The results are the first to be published in a peer-reviewed scientific journal from a double-blind, placebo-controlled study conducted to assess the impact of the PROMETA Treatment Program on methamphetamine dependence.

    Lung Rx, LLC, a wholly-owned subsidiary of United Therapeutics Corporation (Nasdaq: UTHR), announced today that it has entered into a Development Agreement with ImmuneWorks, Inc. to pursue development of ImmuneWorks' lead compound, IW001, a purified bovine Type V Collagen oral solution for the treatment of Idiopathic Pulmonary Fibrosis (NYSEARCA:IPF) and Primary Graft Dysfunction (NYSEARCA:PGD) in patients receiving lung transplant. The parties expect to commence human clinical testing in 2010.  In November 2009, the U.S. Food and Drug Administration granted orphan drug exclusivity to IW001.

    MDS Inc. (TSX: MDS; NYSE: MDZ), a leading provider of products and services to the global life sciences markets, today announced that it has signed agreements to divest its remaining MDS Pharma Services Early Stage business, which provides Discovery through Phase IIa clinical trial services to biotechnology and pharmaceutical companies, for $45 million and certain minority equity interests. The $45 million purchase price includes a five-year, $25 million note and $20 million in cash that will be adjusted for working capital and other items; after currently projected adjustments, the $20 million cash payment is estimated to result in net cash proceeds of approximately $7 million.

    At its annual investor R&D Day today, Micromet, Inc. (Nasdaq: MITI) outlined the design of a registration study for the Company's lead product candidate blinatumomab in acute lymphocytic leukemia (NYSE:ALL), highlighted clinical data demonstrating the breadth of blinatumomab's activity in B-cell non-Hodgkin's lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.

    NMT Medical, Inc. (NASDAQ: NMTI) today announced that it expects to report full year 2009 revenues of approximately $13.2 million – within the Company’s previously-announced guidance range of $13 million to $14 million.

    NeuroMetrix, Inc. (Nasdaq: NURO), a health care company transforming patient care through neurotechnology, today announced its financial results for the three months and year ended December 31, 2009.

    St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval of its USB cellular adaptor for the Merlin@home™ transmitter, a system that allows important patient data from an implantable cardiac device to be wirelessly downloaded and securely transmitted via telephone for review by a physician. The new USB adaptor allows patients using a Merlin@home transmitter to transfer data to their physician over the cellular network, in addition to the existing landline service previously available.

    “The USB cellular adaptor allows patients who frequently travel or relocate to be free of the restrictions of a traditional telephone line,” said Dr. Helen Høgh Petersen, of Rigshospitalet in Copenhagen, Denmark. “This addition to the remote monitoring system helps to ensure that patients can stay connected with their device follow-up clinic wherever they may live or travel.”

    StemCells, Inc. (Nasdaq:STEM) announced today that its proprietary HuCNS-SC® human neural stem cells have been used to treat the first patient enrolled in its Phase I clinical trial in Pelizaeus-Merzbacher Disease (NASDAQ:PMD), a myelination disorder that afflicts male children. The stem cells were administered yesterday at the University of California, San Francisco (UCSF) Children's Hospital by direct injection into the brain of a patient with connatal PMD, the most severe form of the disease.This marks the first time that neural stem cells have been transplanted as a potential treatment for a myelination disorder, and the second clinical trial involving the use of HuCNS-SC cells in a neurodegenerative disease.

    Strategic Diagnostics Inc. (Nasdaq: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, today announced it will be doing business as SDIX (Strategic Diagnostics Inc. d/b/a SDIX).

    Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) will release its fourth quarter and full year 2009 financial results on February 23, 2010, after the stock market closes, and will host a conference call at 8:30 AM Eastern Time on February 24, 2010.

    XenoPort, Inc. (Nasdaq: XNPT) announced today that it will release its fourth quarter financial results on February 22, 2010 at approximately 4:30 p.m. Eastern Time.

    YM BioSciences Inc. (Amex: YMI, TSX:YM), announced that it has been granted two additional patents in the US for AeroLEF(NYSE:R), the Company's proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe acute pain. US patent numbers 7,648,981 and 7,648,982 extend the life of YM's AeroLEF patent estate in the US to 2024. The Company also announced that AeroLEF's patent estate has expanded to include other territories with the issuance of European patent number 1,603,533 and several patent allowances in China, India, Mexico and other territories.

    "These patents strengthen and extend the patent protection for AeroLEF in the US, and also expand the global market for this unique and potentially first in class product," said David Allan, CEO of YM BioSciences. "The scientific pedigree and unique advantages of this product have been established and its safety and efficacy have been demonstrated in numerous clinical trials. AeroLEF has met all endpoints in each of its trials including a randomized Phase II trial and is currently being prepared for late-stage development internationally."
    Feb 11 11:15 PM | Link | Comment!
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  • Hearing some interesting developments on the horizon for $NWBO. Did an article on them yesterday. Looks promising. http://bit.ly/NWBOnews
    Jul 12, 2011
  • ($RXPC.PK 3 of 3) If it were bad news, chances are they'd have something by now, since delisting decisions are usually handed down quickly.
    Apr 19, 2011
  • ($RXPC.PK 2 of 3) a listing extension would go until July [when the stock would have to be over $1 to continue being listed on Amex].
    Apr 19, 2011
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